End Stage Renal DiseaseEarly Phase 1NCT02695641

Reduction of Plasma Free VEGF-A Using Low-dose Bevacizumab in Hemodialysis Patients

A Early Phase 1 study testing 1.25mg bevacizumab and 2.50mg bevacizumab in people with End Stage Renal Disease and Hemodialysis Vascular Access Failure, run by Mayo Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: End Stage Renal Disease, Hemodialysis Vascular Access Failure
What is being tested?: 1.25mg bevacizumab and 2.50mg bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Aug 2019to Nov 2021
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 and 85 years old, inclusive
Patients with end stage renal disease (ESRD) who are currently undergoing hemodialysis treatment through an upper extremity fistula
Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to Day 1
Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase ≤2x upper limit of normal or international normalized ratio (INR) ≤ 1.5 prior to Day 0 or INR ≤ 2 if on anticoagulant therapy.
Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
If female and of childbearing years, must have a negative serum pregnancy test at the screening visit (Visit 1). Both female patients of childbearing potential and male patients with childbearing potential partners must be willing to use contraception from the time of screening to completion of the study
Life expectancy of at least 1 year

Who cannot join

Known sensitivity to bevacizumab or prior treatment with any medication known to target VEGF
Current use of medications that are known to interact with the safety and efficacy of bevacizumab (most commonly: Antineoplastics (Anthracyclines), Belimumab, Bisphosphonate Derivatives, Clozapine, Dipyrone, Irinotecan, Sorafenib, and Sutent)
History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
Significant uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 100 mm Hg);
Stroke within six (6) months of study entry (Day 1)
Treatment with any investigational drug/ device within 60 days prior to study entry (Day1)

Show all 19Show fewer

Treatment with vitamin K-antagonists or direct thrombin inhibitors with an INR ≥2
All patients (including both female patients of childbearing potential and male patients with childbearing potential partners) who do not use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly), e.g. implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
Malignancy or treatment for malignancy within the previous 6 months
Immunodeficiency including AIDS / HIV or Active autoimmune disease
Documented hypercoagulable state or history of 2 or more deep vein thromboses (DVTs) or other spontaneous intravascular thrombotic events
Bleeding diathesis or Anemia with a hematocrit level of less than 30%
A prothrombin time or a partial thromboplastin time more than 1.2 times the upper limit of normal, or absolute platelet counts below the lower limit of normal; an absolute neutrophil count below 1,500/mm3
Active local or systemic infection (WBC > 15,000/mm3)
Gastrointestinal ulcer or bleeding, or wound dehiscence
Scheduled elective surgery within 2 months of start date
Known serious allergy to aspirin or penicillin
Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of bevacizumab
Employees of the sponsor or patients who are employees or relatives of the investigator

About this study

Official title: A Phase 0 Study to Evaluate the Pharmacokinetics of Low-dose Bevacizumab and Its Efficacy on Reducing Plasma Free Vascular Endothelial Growth Factor-A (VEGF-A) in Hemodialysis Patients

The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in hemodialysis patients. This information will be used to plan a phase 1 clinical trial evaluating bevacizumab's role in hemodialysis vascular access failure.

Read the detailed description

It has been found that hemodialysis arteriovenous fistula failure is partly mediated through a VEGF pathway. The administration of bevacizumab (a VEGF-A monoclonal antibody) in arteriovenous fistula (AVF) murine models at a dose of 5mg/kg (a standard chemotherapeutic dose) has shown a significant reduction in stenosis formation and an overall improvement in vascular remolding. However, previous pharmacokinetic human studies have shown that bevacizumab administered at a low dose of 1.25mg intravitreally (ocular neovascularization patients) is sufficient enough to suppress circulating VEGF-A levels up to 30 days post administration. A chart review on 14 hemodialysis patients receiving an arteriovenous access and intravitreal bevacizumab has demonstrated a significant improvement in patency (HR: 0.45, p-value: 0.037) when compared to controls. Prior to a phase 1 trial, it is essential to determine if intravenous administration of bevacizumab demonstrates the same pharmacokinetics and bio-response profile as intravitreal administration, and to determine the optimal dose and frequency. This phase 0 study will be conducted in 10 existing hemodialysis patients at a dose of 1.25mg with a potential dose escalation to 2.5mg if optimal results are not seen. The findings from this study can have a substantial clinical impact not only in ESRD patients but also in patients receiving other vascular or endovascular procedures.

Conditions: End Stage Renal Disease, Hemodialysis Vascular Access Failure
Being tested: 1.25mg bevacizumab, 2.50mg bevacizumab
Keywords: Arteriovenous Fistula, Arteriovenous Graft, Bevacizumab, Hemodialysis, VEGF, Avastin
Medical subject headings: Kidney Failure, Chronic, Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1.25mg bevacizumabDrug
Also called Avastin
Bevacizumab is a monoclonal antibody against VEGF-A. 1.25mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.
2.50mg bevacizumabDrug
Also called Avastin
Bevacizumab is a monoclonal antibody against VEGF-A. 2.50mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.

Study groups in NCT02695641
Study group	Role	What they receive
Stage 1 - Low dose administration	Experimental	Ten hemodialysis patients will receive IV infusion treatment with 1.25mg bevacizumab and undergo serial blood draws on Days 0, 1, 3, 6, 10, 15, 22, and 29 during dialysis sessions. ELISA will be performed to evaluate drug serum concentration and corresponding plasma free VEGF-A levels (pg/ml). The safety and pharmacokinetic/dynamic (PK/PD) data will be analysed and ≥50% VEGF-A suppression retained from baseline by Day 15 will be considered successful. If target outcomes are met in stage 1, the study will be terminated, otherwise the study will progress to stage 2. Receives: Drug: 1.25mg bevacizumab
Stage 2 - Dose escalation	Experimental	If outcomes are not met in stage 1, Ten additional hemodialysis patients will receive IV infusion treatment with 2.50mg bevacizumab treatment. They will undergo serial blood draws on Days 0, 1, 3, 6, 10, 15, 22, and 29 during dialysis sessions. ELISA will be performed to evaluate drug serum concentration and corresponding plasma free VEGF-A levels (pg/ml). The safety and PK/PD data will be analysed and ≥50% VEGF-A suppression retained from baseline by Day 15 will be considered successful. If target outcome is not met, the study will be terminated. Receives: Drug: 2.50mg bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Serum concentration of bevacizumab (nM)
Obtained through serial blood draws and measured through ELISA.
Measured: baseline, 4 weeks
Change in plasma free VEGF-A levels (pg/ml)
Obtained through serial blood draws and measured through ELISA. ≥50% suppression from baseline retained by Day 15 will be considered successful.
Measured: baseline, 4 weeks

Secondary outcomes (1)

Safety Profile/ Adverse Events (NCI-CTCAE v. 4.0) monitoring
Monitoring of drug infusion reactions and adverse event development on subsequent follow-up visits at dialysis centers. Monitoring will include but will not be limited to allergic reactions or anaphylaxis, development of hypertension, excessive bleeding or thromboembolic events
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 2019Nov 2021

First posted1 Mar 2016 (estimated)
Study start1 Aug 2019 (estimated)
Primary completionAug 2020 (estimated)
Study completionNov 2021 (estimated)

Why it stopped: Unable to enroll patients for the trial.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02695641
Sponsor's protocol ID: 15-007414
Status last verified: Jun 2026
First submitted: 25 Feb 2016
Last updated: 24 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Yang B, Janardhanan R, Vohra P, Greene EL, Bhattacharya S, Withers S, Roy B, Nieves Torres EC, Mandrekar J, Leof EB, Mukhopadhyay D, Misra S. Adventitial transduction of lentivirus-shRNA-VEGF-A in arteriovenous fistula reduces venous stenosis formation. Kidney Int. 2014 Feb;85(2):289-306. doi: 10.1038/ki.2013.290. Epub 2013 Aug 7.
PubMed 23924957
Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.
PubMed 25001321
Papadopoulos N, Martin J, Ruan Q, Rafique A, Rosconi MP, Shi E, Pyles EA, Yancopoulos GD, Stahl N, Wiegand SJ. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis. 2012 Jun;15(2):171-85. doi: 10.1007/s10456-011-9249-6.
PubMed 22302382
Matsuyama K, Ogata N, Matsuoka M, Wada M, Takahashi K, Nishimura T. Plasma levels of vascular endothelial growth factor and pigment epithelium-derived factor before and after intravitreal injection of bevacizumab. Br J Ophthalmol. 2010 Sep;94(9):1215-8. doi: 10.1136/bjo.2008.156810. Epub 2010 Jun 10.
PubMed 20538658
Wang D, Choi KS, Lee SJ. Serum concentration of vascular endothelial growth factor after bilateral intravitreal injection of bevacizumab. Korean J Ophthalmol. 2014 Feb;28(1):32-8. doi: 10.3341/kjo.2014.28.1.32. Epub 2014 Jan 21.
PubMed 24505199
Zehetner C, Kirchmair R, Huber S, Kralinger MT, Kieselbach GF. Plasma levels of vascular endothelial growth factor before and after intravitreal injection of bevacizumab, ranibizumab and pegaptanib in patients with age-related macular degeneration, and in patients with diabetic macular oedema. Br J Ophthalmol. 2013 Apr;97(4):454-9. doi: 10.1136/bjophthalmol-2012-302451. Epub 2013 Feb 5.
PubMed 23385630
Garnier-Viougeat N, Rixe O, Paintaud G, Ternant D, Degenne D, Mouawad R, Deray G, Izzedine H. Pharmacokinetics of bevacizumab in haemodialysis. Nephrol Dial Transplant. 2007 Mar;22(3):975. doi: 10.1093/ndt/gfl664. Epub 2006 Nov 8. No abstract available.
PubMed 17093010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 0 Study to Evaluate the Pharmacokinetics of Low-dose Bevacizumab and Its Efficacy on Reducing Plasma Free Vascular Endothelial Growth Factor-A (VEGF-A) in Hemodialysis Patients
ClinicalTrials.gov ID: NCT02695641
Acronym / sponsor ID: 15-007414
Conditions: End Stage Renal Disease, Hemodialysis Vascular Access Failure
Keywords: Arteriovenous Fistula, Arteriovenous Graft, Bevacizumab, Hemodialysis, VEGF, Avastin
Phase: Early Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Unable to enroll patients for the trial.
Enrolment: 0 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Aug 2019 (estimated)
Primary completion: Aug 2020 (estimated)
Study completion: Nov 2021 (estimated)
First posted: 1 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Stage 1 - Low dose administration	Experimental	Drug: 1.25mg bevacizumabTen hemodialysis patients will receive IV infusion treatment with 1.25mg bevacizumab and undergo serial blood draws on Days 0, 1, 3, 6, 10, 15, 22, and 29 during dialysis sessions. ELISA will be performed to evaluate drug serum concentration and corresponding plasma free VEGF-A levels (pg/ml). The safety and pharmacokinetic/dynamic (PK/PD) data will be analysed and ≥50% VEGF-A suppression retained from baseline by Day 15 will be considered successful. If target outcomes are met in stage 1, the study will be terminated, otherwise the study will progress to stage 2.
Stage 2 - Dose escalation	Experimental	Drug: 2.50mg bevacizumabIf outcomes are not met in stage 1, Ten additional hemodialysis patients will receive IV infusion treatment with 2.50mg bevacizumab treatment. They will undergo serial blood draws on Days 0, 1, 3, 6, 10, 15, 22, and 29 during dialysis sessions. ELISA will be performed to evaluate drug serum concentration and corresponding plasma free VEGF-A levels (pg/ml). The safety and PK/PD data will be analysed and ≥50% VEGF-A suppression retained from baseline by Day 15 will be considered successful. If target outcome is not met, the study will be terminated.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients between 18 and 85 years old, inclusive
Patients with end stage renal disease (ESRD) who are currently undergoing hemodialysis treatment through an upper extremity fistula
Hemoglobin ≥8g/dL and platelet count ≥100,000/mm3 prior to Day 1
Adequate liver function, defined as serum bilirubin ≤1.5 mg/dL; gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase ≤2x upper limit of normal or international normalized ratio (INR) ≤ 1.5 prior to Day 0 or INR ≤ 2 if on anticoagulant therapy.
Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures

Key exclusion criteria (19 listed)

Known sensitivity to bevacizumab or prior treatment with any medication known to target VEGF
Current use of medications that are known to interact with the safety and efficacy of bevacizumab (most commonly: Antineoplastics (Anthracyclines), Belimumab, Bisphosphonate Derivatives, Clozapine, Dipyrone, Irinotecan, Sorafenib, and Sutent)
History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months of study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
Significant uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 100 mm Hg);
Stroke within six (6) months of study entry (Day 1)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1.25mg bevacizumabAlso: AvastinBevacizumab is a monoclonal antibody against VEGF-A. 1.25mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.	Drug	Stage 1 - Low dose administration
2.50mg bevacizumabAlso: AvastinBevacizumab is a monoclonal antibody against VEGF-A. 2.50mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.	Drug	Stage 2 - Dose escalation

Primary outcome

Change in Serum concentration of bevacizumab (nM)
Time frame: baseline, 4 weeks
Obtained through serial blood draws and measured through ELISA.
Change in plasma free VEGF-A levels (pg/ml)
Time frame: baseline, 4 weeks
Obtained through serial blood draws and measured through ELISA. ≥50% suppression from baseline retained by Day 15 will be considered successful.

1 secondary outcome

Safety Profile/ Adverse Events (NCI-CTCAE v. 4.0) monitoring
Time frame: 4 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Background: PubMed 23924957Yang B, Janardhanan R, Vohra P, Greene EL, Bhattacharya S, Withers S, Roy B, Nieves Torres EC, Mandrekar J, Leof EB, Mukhopadhyay D, Misra S. Adventitial transduction of lentivirus-shRNA-VEGF-A in arteriovenous fistula reduces venous stenosis formation. Kidney Int. 2014 Feb;85(2):289-306. doi: 10.1038/ki.2013.290. Epub 2013 Aug 7.
Background: PubMed 25001321Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.
Background: PubMed 22302382Papadopoulos N, Martin J, Ruan Q, Rafique A, Rosconi MP, Shi E, Pyles EA, Yancopoulos GD, Stahl N, Wiegand SJ. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis. 2012 Jun;15(2):171-85. doi: 10.1007/s10456-011-9249-6.
Background: PubMed 20538658Matsuyama K, Ogata N, Matsuoka M, Wada M, Takahashi K, Nishimura T. Plasma levels of vascular endothelial growth factor and pigment epithelium-derived factor before and after intravitreal injection of bevacizumab. Br J Ophthalmol. 2010 Sep;94(9):1215-8. doi: 10.1136/bjo.2008.156810. Epub 2010 Jun 10.
Background: PubMed 24505199Wang D, Choi KS, Lee SJ. Serum concentration of vascular endothelial growth factor after bilateral intravitreal injection of bevacizumab. Korean J Ophthalmol. 2014 Feb;28(1):32-8. doi: 10.3341/kjo.2014.28.1.32. Epub 2014 Jan 21.
Background: PubMed 23385630Zehetner C, Kirchmair R, Huber S, Kralinger MT, Kieselbach GF. Plasma levels of vascular endothelial growth factor before and after intravitreal injection of bevacizumab, ranibizumab and pegaptanib in patients with age-related macular degeneration, and in patients with diabetic macular oedema. Br J Ophthalmol. 2013 Apr;97(4):454-9. doi: 10.1136/bjophthalmol-2012-302451. Epub 2013 Feb 5.
Background: PubMed 17093010Garnier-Viougeat N, Rixe O, Paintaud G, Ternant D, Degenne D, Mouawad R, Deray G, Izzedine H. Pharmacokinetics of bevacizumab in haemodialysis. Nephrol Dial Transplant. 2007 Mar;22(3):975. doi: 10.1093/ndt/gfl664. Epub 2006 Nov 8. No abstract available.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sanjay Misra, MD principal investigator

Mayo Clinic

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 1.25mg bevacizumab and 2.50mg bevacizumab in people with End Stage Renal Disease and Hemodialysis Vascular Access Failure, run by Mayo Clinic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum concentration of bevacizumab (nM) (time frame: baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02695641, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.